Prascend license

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maybedaisy

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Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act, this approval qualifies for FIVE years of marketing exclusivity beginning on the date of the approval because no active ingredient of the new animal drug has previously been approved. (Expires 9/7/2016) read on another forum that the current license on prascend expires this year. Does this mean cheaper prascend. I hope so. It's so expensive.
 
Hopefully if other companies start producing it for equine use then yes it could do. Just depends on if a rival company does decide they want to produce a version of the product and what they choose to price it at (as it's the competition between companies that would bring prices down). It's a fairly widely used drug so fingers crossed. Would make me rather happy if that were the case as that date is a few months before my year of the insurance paying for it runs out!
 
Actually no, the company re-licenses the product. Or rather the manufacturer submits a dossier and requests a license renewal. If everything is in line with what is expected, the Health Authority will approve the license renewal.

What you are looking for is the PATENT expiration (for human products this is 15 years after first authorisation).
 
I doubt its that lucrative. I don't think its used much in humans now, and the PPID horse market will be relatively small even though to us it seems like there are lots of us affected. Still a pain it went up so much, I was using it in ye olden days and it was a lot more affordable.
 
We have 4 with Cushings on our yard. More and more horses are being diagnosed. I blame glysophate. Its an expanding market and they have found an outlet for a drug that they could not longer use on humans due to the side effect. Sadly there is no appetite to find a cause or cure.
 
Assuming you're based in the UK/EU rather than the US, which is where that legislation relates to, there are 2 deadlines after which manufacturers can apply for a generic product.

Each new drug gets 10 years of market exclusivity, for Prascend this expires in 2020 (in the UK) so a while to wait. Then you have to wait until the patent expires. Typically patents last 25 years, however they're normally filed right at the start of drug development (which takes 10-15 years), so they often expire around the time market exclusivity runs out.

You then have to rely on a generic drug company wanting to licence the product, which will depend on how big the market is.

I hope this is helpful, I work in regulatory affairs.
 
Hedge_pig said:
Assuming you're based in the UK/EU rather than the US, which is where that legislation relates to, there are 2 deadlines after which manufacturers can apply for a generic product.

Each new drug gets 10 years of market exclusivity, for Prascend this expires in 2020 (in the UK) so a while to wait. Then you have to wait until the patent expires. Typically patents last 25 years, however they're normally filed right at the start of drug development (which takes 10-15 years), so they often expire around the time market exclusivity runs out.

You then have to rely on a generic drug company wanting to licence the product, which will depend on how big the market is.

I hope this is helpful, I work in regulatory affairs.
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This was Periglode (not sure of spelling) and then it was relicensed as Prascend and the costs literally quadrupled. I think it's completely immoral. The drug company had made their money and then took complete advantage of a captive audience. Yes I know they are in business but this is just taking the mick. So, geniune question..when would the license term start? As if all the company did was change name and license for equine use.
 
Luci07 said:
This was Periglode (not sure of spelling) and then it was relicensed as Prascend and the costs literally quadrupled. I think it's completely immoral. The drug company had made their money and then took complete advantage of a captive audience. Yes I know they are in business but this is just taking the mick. So, geniune question..when would the license term start? As if all the company did was change name and license for equine use.
Click to expand...

Prascend was licensed in the UK in March 2010, prior to that pergolide wasn't licensed for use in horses.
 
Not sure of the history of pergolide, Prascend was only licenced in 2010 but sounds like there was another product containing pergolide (the active ingredient) before this. Whoever the innovator company is had/has the market exclusivity and patent protection for pergolide, if the active has been on the market for a long time it's likely that this period is up.

The problem with vet meds is that there isn't a massive amount of competition if the market isn't big enough, it's not like human meds where you can still make money being the 29th company marketing generic ibuprofen. For most companies it's just not worth paying out to get a licence for a generic product in a small market, so the brand leader is free to hike up the price as much as they like.
 
Until the actual drug laws changed you could buy pergolide. Now that you cannot use a human drug where a veterinary equivalent is available, it has to be the branded Prascend. With the fall in human use and a convenient change in the law you cannot really be surprised they have upped the cost to a captive market, which is still relatively small. Yes, more horses are being diagnosed - it wasn't even known when I was a child - but horses are still a luxury and not funded by the NHS. We pay a lot for many drugs. Having owned 3 PPID horses and seen the good pergolide does, it's worth it. Yes, I'd rather have the cheaper generic pergolide but at the end of the day if you want horses you accept the related costs. Some people spend far more on pointless supplements and treats than others do on medication.
 
You cannot blame the drug company they had to re licence it as its use in humans was making it uneconomic to manufacture so they had to go through all the hoops to obtain animal licencing which is not a cheap excersise if they hadnt I suspect it would not have been available at all now.
 
Actually it's not a change in the law, it's still the case that you can use a human medicine if a vet drug isn't available, but as soon as a product is licenced as a veterinary medicine it has to be prescribed over the human medicine.

Veterinary medicines often cost more than human, the market is smaller but the regulatory demands to get the product to market are the same. The cost of regulatory activities is around 2% of turnover for human products and about 13% for veterinary products, the drug companies have to make their money back somehow.

Vets also need to make money, to be able to store and prescribe medicines they also need to jump through various regulatory hoops; they have to be licenced and inspected, trained, have appropriate facilities for storage etc.

Then also they're not subsidised by the NHS, if we paid the real cost of human medicines the contrast wouldn't seem so stark. There's a lot of very good reasons why vet meds cost what they do.
 
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